Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

The Families Advocate, LLC v. Sanford Clinic North

United States District Court, D. North Dakota

June 7, 2019

THE FAMILIES ADVOCATE, LLC, an Arizona Limited Liability Corporation, as Conservator of D.M., a Minor; and SARINA BONNO and JULIAN MORENO, Individually PLAINTIFFS



         The Court held a hearing on May 30, 2019, and received oral argument on several pending motions in limine (Docs. 160, 201, 203, 235, 239, 246, 247). The Court ruled or partially ruled on some of the motions from the bench and took other motions under advisement. The Court is now prepared to rule, and the following Order memorializes the Court's rulings. To the extent anything in this Order conflicts with statements made from the bench during the hearing, this Order will control.



         This motion seeks to exclude from trial certain-but not all-expert opinions of defense witness Dr. Carolyn Salafia, a placental pathology expert. The motion also seeks to exclude certain opinions of several other defense experts-Drs. Chugani, Farb, Ferrara, Nelson, Radetsky, and Calvin-to the extent those other experts' opinions have incorporated and referenced the disputed testimony and opinions of Dr. Salafia. Plaintiffs object to Dr. Salafia offering testimony as to the proximate cause or causes of the brain injury suffered by D.M. They contend that Dr. Salafia plans to explain to the jury through her testimony a “novel theory that a process sufficient to produce certain microscopic features in the placenta and umbilical cord caused a fetal brain injury to D.M. days before his birth.” (Doc. 161 at 2). Dr. Salafia studied sections of D.M.'s umbilical cord and placenta and concluded that there was evidence of cord trauma, cord compression, an excessively long and coiled cord, long-term exposure of the cord and placenta to meconium, and possible exposure of the fetus to infection or an infectious process in utero. She opined that the injuries to the cord and placenta that she observed occurred more than 24 hours to a week prior to delivery.

         Plaintiffs are concerned that Dr. Salafia will testify that the placental and umbilical cord anomalies she observed proximately caused D.M.'s brain injuries, and further, that she will attempt to time when those brain injuries occurred in utero-something even she concedes she is not qualified to do by virtue of her training and experience. Plaintiffs further claim she cannot point to any published medical literature “that states that a process sufficient to cause these findings in the placenta is also sufficient to cause a fetal brain injury.” Id. at 10. Plaintiffs concede, however, that Dr. Salafia may be qualified to testify “that there is an association between these findings [regarding cord and placental anomalies] and adverse neonatal outcomes, ” but they stress to the Court that “[a]ssociation does not imply causation.” Id. Finally, Plaintiffs argue that Dr. Salafia's testimony about the timing of the appearance of these placental and cord anomalies is likely irrelevant to the case, since “[w]hat is at issue is the cause and timing of D.M.'s brain injury.” Id. (emphasis added). To reinforce this point, they cite to a medical textbook, Pathology of the Placenta: A Practical Guide, for the proposition that fetal malperfusion is not necessarily causative of a particular outcome to a fetus. Id. But the textbook also notes that the types of structural anomalies associated with malperfusion may “at a minimum . . . reduce[] the fetal threshold for tolerating additional intrauterine/intrapartum stressors.” Id.

         A Daubert motion like this one asks the Court to invoke its “gate-keeping function” to ensure that an expert's opinion is “supported by the kind of scientific theory, practical knowledge and experience, or empirical research and testing that permit assessment ‘of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue.'” Robertson v. Norton Co., 148 F.3d 905, 907 (8th Cir.1998) (quoting Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 592-93 (1993)). Whether to exclude or allow expert testimony is committed to the district court's sound discretion, subject to the Federal Rules of Evidence, including Rule 702. Johnson v. Mead Johnson & Co., LLC, 754 F.3d 557, 561 (8th Cir. 2014).

         Rule 702 states:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if: (a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principles and methods to the facts of the case.

         The Eighth Circuit has “boiled down” these requirements into a three-part test:

First, evidence based on scientific, technical, or other specialized knowledge must be useful to the finder of fact in deciding the ultimate issue of fact. This is the basic rule of relevancy. Second, the proposed witness must be qualified to assist the finder of fact. Third, the proposed evidence must be reliable or trustworthy in an evidentiary sense, so that, if the finder of fact accepts it as true, it provides the assistance the finder of fact requires.

Johnson, 754 F.3d at 561 (quoting Polski v. Quigley Corp., 538 F.3d 836, 839 (8th Cir. 2008)).

         When making a Daubert challenge, the Court's objective “is to make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.” Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 152 (1999). To this point, Plaintiffs argued during the hearing on May 30 that the medical literature Defendants cited in their response to the motion-which Defendants contend supports Dr. Salafia's scientific opinions about the negative effects that excessive cord length, cord coiling, and meconium staining, among other noted anomalies, may have on the fetus in utero-does not, in fact, support these opinions. Plaintiffs' counsel went so far as to represent to the Court that Defendants “can't point to a single article where it actually supports what she's trying to say in the first place” and then described Dr. Salafia's opinions on the medical effects of cord length and cord discoloration due to meconium staining as “not based on any scientific literature, including the literature that they cite” and as opinions that are tantamount to “junk science.” Before considering the Daubert factors, the Court finds it necessary to clarify the scope of the parties' disagreement about Dr. Salafia's proposed testimony. First, Defendants represent to the Court that she will not offer an opinion that any of the cord and placental anomalies she observed proximately caused D.M.'s brain injuries. Given that concession, the Court will order that Dr. Salafia not attempt to offer such opinions as to proximate causation at trial. Second, it appears that Plaintiffs have no quarrel with Dr. Salafia describing how she analyzed the cord and placental samples, and then explaining the various features and anomalies she observed in those samples. The sole areas of contention between the parties have to do with Dr. Salafia's testimony that: (1) the anomalies she observed in D.M.'s cord and placenta are generally linked to certain negative outcomes in fetuses and (2) these anomalies in D.M.'s cord must have occurred more than 24 hours to a week prior to delivery.

         Turning to the “boiled down” three-part test in Johnson, the Court must first consider whether Dr. Salafia's proposed, disputed testimony is relevant, in that it must prove potentially useful to the finder of fact in deciding the ultimate issues of fact. After careful consideration, the Court finds that Dr. Salafia's testimony about the placental and cord anomalies she observed, their general association with negative outcomes in fetuses, and their timing in utero are all relevant to the central issue of causation in this case. Second, to be admissible, the Court must find Dr. Salafia qualified to assist the finder of fact in understanding these disputed areas of scientific testimony. Here, the Court finds that Dr. Salafia's education and extensive clinical experience in the area of placental pathology make her qualified to opine on all disputed topics.

         What remains, therefore, is the crux of the dispute: whether Dr. Salafia's opinions on the negative biological indicators generally associated with the cord and placental anomalies that she observed-and the timing of those anomalies-are grounded in accepted scientific principles and methods, or else are so novel and outside the scientific mainstream that they may more properly be characterized as “junk science.” After reviewing the medical literature cited by Defendants in opposition to the motion, the Court concludes that the disputed opinions outlined above appear to be supported by the literature cited, and Plaintiffs' disagreement with Dr. Salafia's opinions goes more to their weight and credibility, rather than to their admissibility. See, e.g., Doc. 186-4 at pp. 1, 2, 9, 23 (“[S]evere fetal consequences” secondary to compression of the cord and coiling in “[e]xcessively long cord[s] >70 cm”[1] may be “present for weeks or months before delivery” and “can cause chronic, intermittent obstruction of blood flow . . . and resultant thrombosis in the fetal circulation, ” as well as “fetal distress, death, or neurologic injury”; excessive cord coiling is “associated with fetal growth restriction and fetal intolerance to labor;” meconium exposure “for a sustained period of time” leads to “damage [to] the amnion, the umbilical cord, and fetal vessels”; and “many hours of meconium exposure are required for gross staining of the umbilical cord, ” which may “manifest[] as necrosis of the vascular smooth muscle of umbilical vessels”); Doc. 186-3 at 5 (noting that meconium staining with associated myonecrosis[2] is associated with “adverse clinical outcomes such as IUGR [Intrauterine Growth Restriction], IUFD [Intrauterine Fetal Death], fetal distress, and low APGAR scores”; and recent studies suggest that 24 hours of more of exposure to meconium may be required “for meconium-filled macrophages to appear in the membranes”).

         The Eighth Circuit has made clear that in performing a Rule 702 analysis, “the district court may evaluate one or all of the following factors: 1) whether the theory or technique can be or has been tested; 2) whether the theory or technique has been subjected to peer review and publication; 3) whether the theory or technique has a known or potential error rate and standards controlling the technique's operation; and 4) whether the theory or technique is generally accepted in the scientific community.” Allen v. Brown Clinic, P.L.L.P., 531 F.3d 568, 573 (8th Cir.2008) (citing Daubert, 509 U.S. at 593-94). In performing this analysis, however, “[t]he focus . . . must be solely on principles and methodology, not on the conclusions that they generate.” Daubert, 509 U.S. at 595. Here, the Court finds that, according to the evidence presented, the principles and methodology used by Dr. Salafia are sound, and her theories have been tested and subjected to scrutiny in publications generated by the scientific community.

         Accordingly, the Motion to Exclude (Doc. 160) with respect to Dr. Salafia is GRANTED IN PART AND DENIED IN PART, in that Dr. Salafia will not be permitted to testify that any of her observations as to D.M.'s umbilical cord and placental anomalies proximately caused his brain injuries, nor may she testify as to the timing of his brain injuries; however, she will be permitted to testify about her observation of cord/placental anomalies, the physiological/biological effects that are generally associated with the presence of these anomalies, and the timing of these anomalies in utero.

         With respect to the motion's request to exclude certain testimony offered by other defense experts, Plaintiffs have failed to adequately justify why these expert opinions should be excluded under Rule 702, and further, Plaintiffs have failed to adequately identify which opinions merit such exclusion and why. Drs. Chugani, Farb, Ferrara, Nelson, Radetsky, and Calvin all relied on the accuracy of Dr. Salafia's analysis of D.M.'s cord and placental samples, and they all referenced the anomalies that Dr. Salafia described in their own expert opinions. As far as the Court understands, the accuracy of Dr. Salafia's analysis of the cord and placental samples is not the subject of this motion.

         Moreover, Plaintiffs have not argued that these other doctors are unqualified by either training or experience to analyze the cord/placental data that Dr. Salafia reported. In point of fact, the motion does not even refer the Court to any specific testimony or opinions by these doctors that merit exclusion.[3] The Motion instead focuses almost exclusively on Dr. Salafia and her testimony-and then tacks on an oblique criticism of Drs. Chugani, Farb, Ferrara, Nelson, Radetsky, and Calvin for incorporating aspects of her report into their own “litigation-driven opinion[s].” (Doc. 161 at 13). In light of the Court's decision above regarding the admissibility of Dr. Salafia's opinions, the Motion with regard to Drs. Chugani, Farb, Ferrara, Nelson, Radetsky, and Calvin relying upon and referencing those opinions in their own reports and testimony is DENIED.


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.